BROOKSVILLE, Fla., Feb. 12, 2019 /PRNewswire-PRWeb/ -- Atlas Analytical Inc., a microbiology and chemistry quality control
The new facility houses laboratories for testing drug product potency, raw material quality, container closure integrity, and includes a validated clean room for testing product sterility. The additional space also gives room for controlled temperature and humidity chambers to store drug product and to confirm shelf life.
"Florida is home to many compounding pharmacies, so it was a natural spot to start this endeavor," says Atlas Co-Founder Tony Grilli. "There are also several state and private colleges offering first class education in the life sciences which makes it a rich source for talent."
Atlas was founded shortly after the New England Compounding Center (NECC) contamination event that claimed over 60 lives. Grilli, a microbiologist with over 25 years of drug industry experience, started the company because he saw a need for quality laboratory support for compounding pharmacies and the life sciences industry in general.
"The FDA Inspection Reports (US 483 Findings) that were coming out in 2014 after NECC showed that the industry was not applying Good Manufacturing Practices to testing or manufacturing. While this was not required of pharmacies at the time, these principles are important to assuring product potency and purity," says Grilli. "I thought the market deserved a laboratory that applied these principles to testing compounded drug product."
Atlas is an FDA registered, cGMP compliant laboratory with a focus on customer service. The lab leads the industry in turn-around times, with product sterility test results available in a single day utilizing validated cutting edge ScanRDI technology. All methods are validated for every product release. This focus on regulatory and service quality has been Atlas's recipe for success.
Aside from compounded pharmacy products, Atlas tests medical devices, biotech, cosmetic, and generic drug product for other manufacturers in the Tampa Bay area and beyond.
"It's personally satisfying to know that quality work is rewarded. We look forward to continued growth at our Brooksville site," says Grilli.
To learn more about Atlas, visit http://www.focus-lab.com/atlas_analytical.
Atlas Analytical Laboratories was founded in 2015 to fill a gap in quality control testing. The founders of Atlas bring together 40 years of compounding and 30 years of analytical microbiology experience. Utilizing the latest technology and validation methods, coupled with a fully automated customer portal, Atlas delivers high quality product testing and rapid turnaround times. http://www.atlasanalytical.com
FOCUS Laboratories is a sister laboratory in Bethlehem, PA. FOCUS specializes in nonsterile product testing and clean room environmental monitoring. It enjoys excellent regulatory status with no 483 observations from its last FDA Audit. FOCUS is ISO 17025:2017 accredited for environmental monitoring and nonsterile microbiology testing. https://focus-lab.com/
SOURCE Atlas Analytical
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